PBI Manufacture Core

PBI制造核心

• 批准号: 8061613
• 负责人: Kenneth Hadlock
• 金额: $ 17.12万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8061613
• 关键词: AIDS Dementia Complex; Anabolism; Animal Model; Animals; Antineoplastic Agents; Archives; Biological; Biological Assay; Biotechnology; Clinical; Clinical Investigator; Clinical Trials; Commit; Comparative Study; Consult; Consultations; Contracts; Development; Documentation; Drug Formulations; Drug Stability; Ensure; GMP lots; Generations; HIV; Human; In Vitro; Investigational Drugs; Investigational New Drug Application; Joints; Label; Lead; Lymphoma; Macaca mulatta; Maintenance; Malignant Neoplasms; Modeling; Monitoring Clinical Trials; Pamphlets; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Phase I Clinical Trials; Phase I/II Trial; Polyamines; Preparation; Production; Program Research Project Grants; Quality Control; Recording of previous events; Records; Regulatory Affairs; Research Personnel; Resistance; Rights; Running; SIV; SIV encephalitis; Sterility; Supervision; Syndrome; Testing; Time; Toxicology; United States Food and Drug Administration; United States National Institutes of Health; Update; Vial device; Work; Writing; analog; base; chemotherapy; clinical lot; cost; drug development; experience; human subject; inhibitor/antagonist; manufacturing process; nervous system disorder; programs; quality assurance; research clinical testing; small molecule; stability testing; sterility testing

This program project envisions running two small proof of concept phase I clinical trials in human subjects. To facilitate the work of this program project grant, Pathologica will be responsible for all aspects of the manufacture, quality control, and quality assurance required to produce an investigational new drug. This component includes, the manufacture of the compound(s), packaging of the drug(s), stability testing, production of clinical investigator brochures, and filing of the INDs for both trials. The first trial is envisioned to involve the polyamine biosynthesis inhibitor PA-001 in the setting of HIV associated dementia and related syndromes. PA-001 has shown excellent activity against SIV encephalitis in rhesus macaque model (see Project 2: Animal model studies for more details). The compound for the second trial will be chosen based on the results of the in vitro and animal studies performed during the first two years of the program project, but will also be a polyamine biosynthesis inhibitor. Pathologica LLC is fortunate to have rights to evaluate and commercialize many PBIs including the polyamine analog CG47, and the PBI manufacture core will ensure that sufficient quantity and quality of these polyamine analogs will be available for comparative studies with PA-001 as described more fully in Projects 1 and 2 of this program project grant. To provide the drugs Pathologica will be assisted by Dr Fredrick Johnson, who has more than 20 years of experience in the manufacture and quality assurance testing of both small molecule and biological pharmaceutical products.

该项目设想在人类受试者中进行两个小型的概念验证I期临床试验。 为了促进这项计划项目赠款的工作，Pathologica将负责 生产试验用新药所需的生产、质量控制和质量保证。这 组分包括化合物的制造，药物的包装，稳定性测试， 制作临床研究者手册，并对两项试验的IND进行归档。第一次审判是设想 使多胺生物合成抑制剂PA-001参与HIV相关痴呆和相关疾病的治疗， 综合征PA-001在恒河猴模型中显示出针对SIV脑炎的优异活性（参见 项目2：动物模型研究（更多详情）。第二次试验的化合物将根据 根据该计划项目前两年进行的体外和动物研究的结果， 但也是多胺生物合成抑制剂。病理学有限责任公司很幸运， 并将包括多胺类似物CG 47在内的许多PBI商业化，PBI制造核心将 确保足够数量和质量的这些多胺类似物可用于比较 研究与PA-001更充分地描述在项目1和2的这个程序项目补助金。提供 Drugs Pathologica将由Fredrick约翰逊博士协助，他在该领域拥有20多年的经验。 小分子和生物制药产品的生产和质量保证测试。